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The U.S. Food and Drug Administration’s authority to reconsider and rescind earlier classification decisions could be severely limited following a recent federal court ruling. Read More
Manufacturers of nucleic acid amplification test reagents for dengue virus should take a variety of steps, such as optimizing reagents and test procedures for recommended instruments, to prevent false negative or positive results, the U.S. Food and Drug Administration says. Read More
Premarket submissions for flow cytometry devices should include a description of quality controls to ensure the device performs accurately throughout its lifecycle, the FDA says. This should include each analytical parameter reported by the device, including fluorescence intensity measures, when relevant. Read More
Bard’s Lutonix cleared the FDA hurdle, making it the first drug-coated angioplasty balloon catheter to treat peripheral artery disease in the leg approved for use in the U.S. But it could be another year or more before the technology wins over payers. Read More
Given past experience with metal-on-metal joint replacements, the introduction of new prostheses should be both gradual and backed up by new and stronger preclinical and clinical studies, a panel of scientific experts in the EU says. Read More
The FDA’s Circulatory Systems Devices Panel Wednesday recommended approval of Boston Scientific’s Watchman device, giving a nod to the left atrial appendage closure technology for an unprecedented third time. Read More
The FDA and Centers for Medicare & Medicaid Services’ parallel review pilot program continues to face hurdles, even while products released through the program have reached the U.S. market, officials of both agencies say. Read More